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FDA 510(k)

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

K-Number: K000054 · 2000-03-13

ApplicantAdri
Decision Date2000-03-13
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Adri. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K000054. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN?

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Adri. The 510(k) number is K000054.

When did FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN receive FDA 510(k) clearance?

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN received FDA 510(k) clearance on 2000-03-13, under 510(k) number K000054.

Who is the listed applicant for FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN?

The FDA 510(k) record lists Adri as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN?

The FDA product code for FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN is KGN.

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Other records listing Adri as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041268SILVERSITE OR CALGITROLK011618CALGITROL AG SILVER ALGINATE WOUND DRESSINGK963656FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSINGK940404ALGINATE FIBER TOPICAL WOUND DRESSINGK870383ALGINATE WOOL FIBER

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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